Marketing authorisations—regulatory procedures for approval of medicinal products
Marketing authorisations—regulatory procedures for approval of medicinal products

The following Life Sciences guidance note provides comprehensive and up to date legal information covering:

  • Marketing authorisations—regulatory procedures for approval of medicinal products
  • Regulatory framework
  • Impact of Brexit on marketing authorisations
  • EU centralised authorisation procedure
  • Mutual recognition procedure
  • Decentralised procedure
  • National procedure
  • US approval process for a new drug (an NDA)

No medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the MA holder (MAH). The approval of medicinal products is regulated by Directive 2001/83/EC on the Community Code relating to medicinal products for human use (Pharmaceutical Code) which is implemented in the UK by the Human Medicines Regulations 2012, SI 2012/1916 (HMRs).

There are several different routes available to obtain an MA for medicinal products. These are:

  1. the EU centralised procedure

  2. the mutual recognition procedure

  3. the decentralised procedure, and

  4. national procedure

The procedure which should be followed is dictated by the nature of the product involved, therapeutic area and type of licence required (ie where the product is to be sold and whether there are any existing licences in other EU/EEA Member States). There are also several different legal bases upon which an application for an MA can be made. Practice Note: Marketing authorisations—content and form of the application and other practical considerations explores the different types of MA application and their legal bases.

This Practice Note provides an introduction to the authorisation of medicinal products, the various procedures available for obtaining an MA, when each procedure